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临床试验/NCT04811976
NCT04811976Unknown不适用

The Effects of Anxiety and Depression on Stent Restenosis in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention

The First Hospital of Qinhuangdao1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
In-stent restenosis

研究概览

简要总结

Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, the incidence of ISR is as high as 10%-20% at 3-6 months after PCI. So it is necessary to identify the potential risk factors to provide evidence for the prevention of ISR. Current research shows that anxiety and depression are related to the increased risk of major adverse cardiac events and mortality in patients with acute myocardial infarction. But there remains a relative paucity of evidence for the association between anxiety and depression and in-stent restenosis (ISR) .So a retrospective cohort study was conducted in the first hospital of Qinhuangdao in 2015-2020. The patients who underwent coronary angiography 1 year after PCI in our hospital from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Logistic regression model was utilized for analyzing the association of depression and anxiety with the in-stent restenosis (ISR) after PCI.

详细描述

Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, postoperative in-stent restenosis (ISR) is still inevitable. The incidence of ISR is as high as 10%-20% at 3-6 months after PCI. And its prevention and treatment is very difficult clinical problems. So it is necessary to identify the potential risk factors to provide evidence for the prevention of ISR. Current research shows that anxiety and depression are related to the increased risk of major adverse cardiac events and mortality in patients with acute myocardial infarction. But there remains a relative paucity of evidence for the association between anxiety and depression and in-stent restenosis (ISR) .

A retrospective cohort study was conducted in the first hospital of Qinhuangdao in 2015-2020. The patients who underwent coronary angiography 1 year after PCI in our hospital from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Every 3 months until 12 months, the patients were consecutively recruited and followed up. Anxiety and depression were assessed using the Zung self-rating anxiety scale (SAS), self-rating depression scale (SDS) and psychosomatic symptom scale at each follow-up timepoint. Relative clinical information was recorded and analyzed. Logistic regression model was utilized for analyzing the association of depression and anxiety with the in-stent restenosis (ISR) after PCI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of acute coronary syndrome The degree of coronary artery stenosis is greater than 90% The degree of coronary artery stenosis is greater than 75% and there is evidence of ischemia

排除标准

  • Patients who did not receive stents for the first time Patients who had undergone coronary artery bypass grafting Patients with stent implantation due to stent stenosis Patients who had stents implanted for chronic complete coronary artery occlusion Patients with malignant tumors Patients with autoimmune diseases Patients with severe hepatic and renal insufficiency Patients with cardiomyopathy Patients with congenital heart disease Patients with valvular disease Patients present with acute stress events

结局指标

主要结局

In-stent restenosis

时间窗: 1 year

Because of the recurrence of symptoms, patients who have done the PCI more than 12 months do the coronary angiography in our hospital. Two interventionists were assigned to record the coronary angiography and complete the corresponding diagnosis in an independent way. If there was a difference in diagnosis, a third doctor was assigned to perform the correlation analysis and analyze and process the other data of the study subjects by blind method. In-stent restenosis was defined asin-stenosis of lumen diameter ≥50% occurred in the diseased vessels, including the coronary arteries in the stent and at both ends of the stent ≤5 mm from the edge of the stent.

次要结局

  • Other adverse cardiac events(1 year)

研究者

发起方
The First Hospital of Qinhuangdao
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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